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TRAC Locus-inserted CD19-targeting STAR-T Cell Therapy in r/r B-NHL

NCT05631912 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-06

No results posted yet for this study

Summary

The team has developed a chimeric antigen receptor (CAR) based on T cell receptor (TCR) complex, called synthetic TCR and antigen receptor (STAR). Further, the researchers disrupted the endogenous T-cell receptor α constant (TRAC) locus by CRISPR/cas9, and then knocked in the anti-CD19-STAR construct through TRAC endogenous promoter. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of autologous CD19-targeting STAR-T cell therapy will be evaluated in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (B-NHL) . A total of 19 to 38 patients are planned to be enrolled and receive CD19-STAR-T cell infusion. Phase 1 (9 to 18 cases) is dose escalation part, and phase 2 (10 to 20 cases) is expansion cohort part.

Conditions

  • Non-hodgkin Lymphoma,B Cell

Interventions

BIOLOGICAL

Autologous CD19-STAR-T cell

Phase 1 dose escalation (3+3) : dose 1 (1×10\^6 cells/kg) ,dose 2 (3×10\^6 cells/kg) ,dose 3 (1×10\^7 cells/kg); Phase 2 : Appropriate dose

DRUG

Fludarabine

Intravenous fludarabine 25-30 mg/m\^2/day on days -5, -4, and -3.

DRUG

Cyclophosphamide

Intravenous cyclophosphamide 300-500 mg/m\^2/day on days -5, -4, and -3.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Weidong Han, Ph.D · Biotherapeutic Department, Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-12-15
Completion
2025-12-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631912 on ClinicalTrials.gov